11 u – Beurer GL 44 (mg/dL) User Manual
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Beurer GL44 mg/dL
Result of the system accuracy for glucose concentrations <100 mg/dL (<5.55 mmol/L)
Within ±5 mg/dL
(Within ±0.28 mmol/L)
Within ±10 mg/dL
(Within ±0.56 mmol/L)
Within ±15 mg/dL
(Within ±0.83 mmol/L)
55/180 (30,6 %)
111/180 (61,7 %)
175/180 (97,2 %)
Results of the system accuracy for glucose concentrations ≥100 mg/dL (≥5.55 mmol/L)
Within ±5%
Within ±10%
Within ±15%
220/438 (50,2 %)
357/438 (81,5 %)
422/438 (96,3 %)
Results of the system accuracy for combined glucose concentrations between 34.4 mg/dL
(1.9 mmol/L) and 442.8 mg/dL (24.6 mmol/L).
Within ±15 mg/dL or ±15%
(Within ±0.83 mmol/L or ±15%)
597/618 (96,6 %)
In comparison to the YSI, the GL44 met the EN ISO 15197:2013 standard, whereby 95% of the blood
glucose values measured have to fall within the following zones: either ±0.83 mmol/L (±15 mg/dL) of
the measured average value when using the reference measuring procedure for blood glucose con-
centrations <100 mg/dL (<5.55 mmol/L) or ±15% for blood glucose concentrations of ≥100 mg/dL
(≥5.55 mmol/L). 99% of the individual measured blood glucose values must fall within zones A and
B of the Consensus Error Grid (CEG) for diabetes type 1.
Performance evaluation by the user
A study to assess the glucose values of blood samples of capillary blood from the fingertips, which
were obtained from 103 individuals that had no special training, produced the following results:
96.7% within ±15 mg/dL (±0.83 mmol/L) and 95.9% within ±15% of the values obtained in the medi-
cal laboratory with glucose concentrations of at least 100 mg/dL (5.55 mmol/L).
You will find further details and information regarding blood glucose results and various technologies
in generally relevant specialist medical literature.
11 u
saGe
limits
for
specialist
personnel
from
the
healthcare
sector
1. If the patient shows the following symptoms, it may be the case that no correct values can be
displayed:
• Acute dehydration
• Acute hypotension (low blood pressure)
• Shock
• Hyperosmolar hyperglycaemic condition (with or without ketosis)